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Quality Control in Training

2 months ago

Thousand Oaks, United States Takeda Pharmaceutical Full time

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Quality Control in Training

Location: Thousand Oaks, CA

About the role:

You will be responsible for responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas. Additionally, you will provide support for quality systems related items and will participate in quality process improvements for the QC labs.

How you will contribute:

  • Develop an on-the-job training plan with learning goals with your area leaders.
  • Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
  • Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
  • Help manage change control process. Participate in DMAIC and LEAN projects to help the department and facility meet continuous improvement objectives.
  • Support external and internal audits by maintaining audit records, extracting data from databases, creating reports, collecting relevant data.
  • May write, review important documents, records, and reports such as Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines.
  • May also prepare Quality trend reports, serve as gatekeeper for quality systems electronic solutions, and attend and share updates at planning meetings chaired by the QA and Planning department. May perform other duties as assigned.

    What you bring to Takeda:

    • High School degree or equivalent required; bachelor's degree in chemistry or Biological Sciences desirable.
    • Minimum 1 year of related experience in quality operations or equivalent years in biotechnology, pharmaceutical or similar GMP manufacturing environment desirable.
    • Basic knowledge of FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices and Application of Good Documentation Practices.
    • General knowledge of quality systems including exception management, change control, document control.

      Important Considerations

      At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

      • The overall physical exertion of this position requires light to medium work.
      • May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
      • Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
      • May work in a cold, hot or wet environment.
      • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
      • May be required to manage hazardous waste in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
      • May work around Methotrexate, which is a known cell growth inhibitor.
      • May require immunization before performing work within the manufacturing area.
      • The role and schedule will be reassessed after each semester/summer break to align with school schedules.

        More about us:

        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

        Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

        #GMSGQ

        #ZR1

        Takeda Compensation and Benefits Summary

        We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

        For Location:USA - CA - Thousand Oaks - Rancho Conejo

        U.S. Hourly Wage Range:$18.85 - $29.62

        The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. 

         

        U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

        EEO Statement

        Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

        Locations

        USA - CA - Thousand Oaks - Rancho Conejo

        Worker Type

        Employee

        Worker Sub-Type

        Regular

        Time Type

        Part time